Esketamine on Postpartum Depression in Cesarean Section Women (EKET)
Primary Purpose
Esketamine, Postpartum Depression
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Esketamine
Normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Esketamine
Eligibility Criteria
Inclusion Criteria:
- Elective cesarean section;
- 18-40 years;
- Primipara;
- Singleton pregnancy;
- Sign informed consent.
Exclusion Criteria:
- ASA grade III and above;
- Intracranial hypertension;
- Hypertension;
- Severe heart disease;
- Hyperthyroidism patients without treatment or insufficient treatment;
- Liver and kidney dysfunction;
- Preeclampsia or eclampsia;
- Mental disorder, mental retardation;
- Drug abuse and alcoholism;
- Contraindication of intraspinal anesthesia;
- The preoperative EPDS score ≥10;
- Participated in other clinical studies.
Sites / Locations
- Tongji HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
N group
Es group
Arm Description
15 minutes after umbilical cord amputation, the patient was intravenously injected with 10 ml normal saline
15 minutes after umbilical cord amputation, the patient was intravenously injected with 0.25mg/kg esketamine, PCIA regimen: sufentanil 100 μ g, esketamine 80 mg, diluted to 100 ml with 0.9% normal saline, set analgesia pump background infusion dose 2 ml/h, single bolus dose 2 ml, locking time 8 minutes.
Outcomes
Primary Outcome Measures
Edinburgh Postnatal Depression Scale(EPDS) scores
EPDS score is 0-30,and ≥ 10 to indicate depression
Secondary Outcome Measures
Visual Analogue Scale/Score (VAS) score
VAS score is 0-100,and ≥ 30 to indicate the pain needs treatment
total number of PCA compressions
the total number of PCA compressions which the patients pressed
total volume of PCA
the total volume of PCA drugs which the patients needed in 24h after sugery
Full Information
NCT ID
NCT04860661
First Posted
April 20, 2021
Last Updated
July 2, 2023
Sponsor
Ailin Luo
Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Central South University, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of University of South China, Guangdong Women and Children Hospital, Third Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Guangxi Medical University, Dalian Municipal Central Hospital, Shandong Jining No.1 People's Hospital, Maternal and Child Health Hospital of Hubei Province
1. Study Identification
Unique Protocol Identification Number
NCT04860661
Brief Title
Esketamine on Postpartum Depression in Cesarean Section Women
Acronym
EKET
Official Title
Effect of Prophylactic Esketamine on Postpartum Depression in Cesarean Section: A Multicenter, Prospective, Randomized, Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ailin Luo
Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Central South University, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of University of South China, Guangdong Women and Children Hospital, Third Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Guangxi Medical University, Dalian Municipal Central Hospital, Shandong Jining No.1 People's Hospital, Maternal and Child Health Hospital of Hubei Province
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study was to explore the preventive effect of esketamine on postpartum depression in cesarean section, and to evaluate the safety of the drug
Detailed Description
Studies have shown that esketamine can treat clinical refractory depression, the drug takes effect quickly, can quickly eliminate the patient's suicide intention, low-dose maintenance treatment is conducive to the stability of the patient's condition, and less adverse reactions, is the current hot spot of antidepressant drug research. Esketamine has been approved by FDA for the treatment of refractory and suicidal depression, but can it effectively prevent and treat postpartum depression? It is not clear. Based on this, this study aims to explore the preventive effect of prophylactic administration of esketamine on postpartum depression in cesarean section, and evaluate the safety of the drug.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esketamine, Postpartum Depression
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The incidence of PPD: the EPDS scale was assessed by face-to-face or telephone interview of the Puerpera 24 h, 7 d, 30 d, 60 d and 90 d after delivery. EPDS score ≥ 10 was defined as antenatal depression or postpartum emotional disorder.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Assign a researcher to determine the order of patients and coordinate the relationship between researchers;
For each patient, an anesthesiologist was assigned to manage anesthesia and collect intraoperative data;
A researcher who was not aware of the protocol was assigned to conduct preoperative evaluation and postoperative follow-up, and received training on evaluation methods before the study.
Allocation
Randomized
Enrollment
1248 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
N group
Arm Type
Placebo Comparator
Arm Description
15 minutes after umbilical cord amputation, the patient was intravenously injected with 10 ml normal saline
Arm Title
Es group
Arm Type
Experimental
Arm Description
15 minutes after umbilical cord amputation, the patient was intravenously injected with 0.25mg/kg esketamine, PCIA regimen: sufentanil 100 μ g, esketamine 80 mg, diluted to 100 ml with 0.9% normal saline, set analgesia pump background infusion dose 2 ml/h, single bolus dose 2 ml, locking time 8 minutes.
Intervention Type
Drug
Intervention Name(s)
Esketamine
Other Intervention Name(s)
Es group
Intervention Description
After delivery, the parturient was given a loading dose of esketamine, and then a small dose of esketamine was added into PCIA analgesia pump
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Ns group
Intervention Description
10 ml normal saline
Primary Outcome Measure Information:
Title
Edinburgh Postnatal Depression Scale(EPDS) scores
Description
EPDS score is 0-30,and ≥ 10 to indicate depression
Time Frame
up to 90 days after surgery
Secondary Outcome Measure Information:
Title
Visual Analogue Scale/Score (VAS) score
Description
VAS score is 0-100,and ≥ 30 to indicate the pain needs treatment
Time Frame
1 Day before operation
Title
total number of PCA compressions
Description
the total number of PCA compressions which the patients pressed
Time Frame
up to 24 hours after operation
Title
total volume of PCA
Description
the total volume of PCA drugs which the patients needed in 24h after sugery
Time Frame
up to 24 hours after operation
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
The objects of this observation were puerpera with cesarean section
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elective cesarean section;
18-40 years;
Primipara;
Singleton pregnancy;
Sign informed consent.
Exclusion Criteria:
ASA grade III and above;
Intracranial hypertension;
Hypertension;
Severe heart disease;
Hyperthyroidism patients without treatment or insufficient treatment;
Liver and kidney dysfunction;
Preeclampsia or eclampsia;
Mental disorder, mental retardation;
Drug abuse and alcoholism;
Contraindication of intraspinal anesthesia;
The preoperative EPDS score ≥10;
Participated in other clinical studies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Gao, Dr.
Phone
86-27-83663173
Email
fgao@tjh.tjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
aijun xu, Dr.
Phone
86-27-83663173
Email
ajxu@tjh.tjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ailin luo, Dr.
Organizational Affiliation
Department of Anesthesiology of Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Gao, Dr.
Phone
27-83663173
Email
fgao@tjh.tjmu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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Esketamine on Postpartum Depression in Cesarean Section Women
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